Cook Incorporated - FDA 510(k) Cleared Devices
175
Total
153
Cleared
1
Denied
61 devices
Cleared
Jul 17, 2018
Ureteral Dilator Sets, Ureteral Dilators
Gastroenterology & Urology
231d
Cleared
Jun 28, 2018
Angled Tip Ureteral Catheter
Gastroenterology & Urology
58d
Cleared
Jun 22, 2018
Advance Biliary Balloon Catheter
Gastroenterology & Urology
233d
Cleared
May 24, 2018
Safety Wire Guide Introducer
Gastroenterology & Urology
63d
Cleared
May 02, 2018
Cook 810 Set, Desilets-Hoffman Introducer Set
Gastroenterology & Urology
119d
Cleared
May 01, 2018
Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage...
Gastroenterology & Urology
215d
Cleared
Apr 19, 2018
Balloon Catheter and Balloon Ureteral Dilator Set
Gastroenterology & Urology
233d
Cleared
Apr 16, 2018
Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
Gastroenterology & Urology
319d
Cleared
Mar 26, 2018
Black Silicone Filiform Double Pigtail Stent Set
Gastroenterology & Urology
266d
Cleared
Mar 22, 2018
Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
Gastroenterology & Urology
174d
Cleared
Mar 07, 2018
Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
Gastroenterology & Urology
261d
Cleared
Mar 01, 2018
Nathanson Transcystic Bile Duct Stone Exploration Pack
Gastroenterology & Urology
248d
Cleared
Feb 23, 2018
Ultraxx Nephrostomy Balloon Catheter
Gastroenterology & Urology
267d
Cleared
Feb 16, 2018
Renal Access Cobra Catheter, Kumpe Access Catheter
Gastroenterology & Urology
260d
Cleared
Feb 01, 2018
Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip...
Gastroenterology & Urology
241d
Cleared
Dec 15, 2017
Strange Bile Duct Stone Exploration Set
Gastroenterology & Urology
14d
Cleared
Dec 13, 2017
Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral...
Gastroenterology & Urology
142d
Cleared
Dec 12, 2017
Wittich Nitinol Stone Basket
Gastroenterology & Urology
260d
Cleared
Nov 22, 2017
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
Gastroenterology & Urology
117d
Cleared
Nov 17, 2017
Gastric Sizing Balloon Catheter
Gastroenterology & Urology
23d
Cleared
Nov 07, 2017
NCompass Nitinol Stone Extractors
Gastroenterology & Urology
41d
Cleared
Oct 19, 2017
Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set,...
Gastroenterology & Urology
59d
Cleared
Sep 14, 2017
Entuit Start Initial Placement Gastrostomy Set
Gastroenterology & Urology
225d
Cleared
Aug 28, 2017
Salle Intraoperative Pyeloplasty Stent Set
Gastroenterology & Urology
237d
Cleared
Jul 28, 2017
Williams Cystoscopic Injection Needle
Gastroenterology & Urology
57d